Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003878
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Carmustine Implants in Treating Patients With Brain Metastases
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving the drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor
PURPOSE Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor
Detailed Description:
OBJECTIVES
Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant Gliadel wafers
Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment
Determine the median 6-month 1-year and 2-year survival of these patients on this regimen
Determine the incidence and severity of cognitive function loss of these patients on this regimen
Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen
OUTLINE Patients receive up to 8 polifeprosan 20 with carmustine implants Gliadel wafers implanted in the resected tumor cavity
Patients are followed on day 7 or day of discharge at 1 month 3 months every 3 months for 21 months and then for survival
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 30 months
Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant Gliadel wafers
Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment
Determine the median 6-month 1-year and 2-year survival of these patients on this regimen
Determine the incidence and severity of cognitive function loss of these patients on this regimen
Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen
OUTLINE Patients receive up to 8 polifeprosan 20 with carmustine implants Gliadel wafers implanted in the resected tumor cavity
Patients are followed on day 7 or day of discharge at 1 month 3 months every 3 months for 21 months and then for survival
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 30 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NABTT-9802 | None | None | None |
| JHOC-NABTT-9802 | None | None | None |